Tsis ntev los no, Tianjin Hongri Pharmaceutical tau tshaj tawm tias nws cov chaw muag khoom ncaj ncees Tianjin Hongri Jiandakang Pharmaceutical Technology Co., Ltd. tau xa daim ntawv thov kev lag luam rau kev txhaj tshuaj toluene sulfonamide pom zoo los ntawm NMPA rau qhov qhia txog kev mob qog noj ntshav hauv nruab nrab uas tsis yog me me nrog kev ua pa hnyav.
Hom mob ntsws cancer hauv tsev kawm ntawv 1 cov tshuaj tshiab no thaum kawg tau pom zoo rau kev ua lag luam tom qab ze li 20 xyoo ntawm kev tshawb fawb thiab kev loj hlob thiab 5 xyoo kev tshuaj xyuas los ntawm Academician Zhong Nanshan.
Tam sim no, tsuas yog Honggri Pharmaceutical hauv Suav teb tau pom zoo rau toluenesulfamide API, uas yog thawj API tshiab tau pom zoo hauv Suav teb. Cov xwm txheej ntawm qhov API no tau pom tias yog "A" ntawm CDE cov ntaub ntawv raw pob ntawv sau npe cov ntaub ntawv platform, thiab nws tau dhau CDE tshuaj xyuas thiab kev pom zoo. Daim ntawv ceeb toom siv tau mus txog rau thaum lub Kaum Ib Hlis 14, 2027.
Toluenesulfonamide txhaj, uas tau pom zoo rau kev lag luam tib lub sijhawm raws li toluenesulfonamide API, tau sau npe ua Chav Kawm 1 cov tshuaj tshiab nrog cov lus qhia ntawm 5ml: 1.65g. Tus naj npawb pom zoo yog National tshuaj pom zoo tus naj npawb H20220031, thiab hnub siv tau ntawm tus lej pom zoo kuj yog lub Kaum Ib Hlis 14, 2027. Tus tuav yog Tianjin Hongri Jiandakang Pharmaceutical Technology Co., LTD.
Toluenesulfonamide txhaj tshuaj yog tsim los ntawm Academician Zhong Nanshan. Raws li cov tshuaj tshiab tshiab rau kev kho cov qog nqaij hlav, cov tshuaj no tau xaiv ntau rau cov qog hlwb, thiab nws yog thawj zaug pom zoo tshuaj ablative tshuaj rau intratumor hauv zos txhaj tshuaj los ntawm fiberoptic bronchoscopy hauv Suav teb. Nws kuj yog thawj cov tshuaj uas tau qhia los txo cov hlab ntsws loj hauv cov neeg laus uas muaj mob qog noj ntshav hauv nruab nrab ntawm lub ntsws (NSCLC), ua kom muaj qhov sib txawv hauv kev ua pa ntawm kev siv tshuaj kho mob.
Txoj kev mus rau kev lag luam rau cov tshuaj tshiab tau ntev thiab winding.
Daim ntawv thov kev kho mob rau kev txhaj tshuaj toluenesulfonamide tau xa tuaj thaum lub Kaum Ib Hlis 21, 2003, thiab thawj tus neeg thov kev kho mob yog Beijing Jiandakang New Drug Development Co., LTD.
Tom qab kev hloov pauv ntawm cov cuab yeej cuab tam kev txawj ntse thiab kev ua tswv cuab, daim ntawv teev npe tau raug rho tawm hauv 722 cov ntaub ntawv kho mob tus kheej-xyuas. Thaum kawg, Tianjin Hongriya Pharmaceutical tau thov rau daim ntawv thov thiab tsim cov tshuaj toluene sulfonamide API thiab toluene sulfonamide txhaj, uas tau txais los ntawm CDE hauv 2018. Nyob rau hauv nruab nrab, ob puag ncig ntawm cov ntaub ntawv ntxiv tau dhau los. Thaum kawg, tom qab ze li 5 xyoos ntawm kev tshuaj xyuas, lub tuam txhab tau txais daim ntawv teev npe tsim nyog.
Ntxiv rau qhov kev pom zoo, cov ntaub ntawv pej xeem qhia tau hais tias toluenesulfamide kuj tau tshawb fawb soj ntsuam txog kev mob qog noj ntshav siab (theem 2), mob ntsws cancer siab heev (theem 2) thiab cov qog nqaij hlav malignant superficial (theem 2), thiab cov kev sim tshuaj muaj feem xyuam. ua tiav. Kev sim tshuaj Phase I tau pom tias toluenesulfonamide zoo hauv kev kho mob qog noj ntshav mis, mob qog noj ntshav ntawm daim tawv nqaij, mob qog noj ntshav nasopharyngeal thiab mob qog noj ntshav.
Tam sim no, mob qog noj ntshav tau dhau los ua tus tua neeg noj qab haus huv tshaj plaws ntawm cov neeg nyob hauv nroog Suav, thiab qhov xwm txheej tau nce ntxiv thiab dhau los ua hluas. Ntawm lawv, mob qog noj ntshav tau dhau los ntawm "tus huab tais ntawm cov qog nqaij hlav" mob qog noj ntshav yog thawj. Raws li Lub Koom Haum Ntiaj Teb Kev Tshawb Fawb Txog Kev Tshawb Fawb (IARC), kwv yees li 816, 000 cov neeg mob tshiab ntawm mob ntsws cancer thiab 715,000 cov neeg tuag tau tshaj tawm xyoo 2020. Qhov xwm txheej ntawm mob ntsws cancer nyob ruaj khov ntawm qhov siab. qib, thiab tus naj npawb ntawm cov neeg mob tshiab yog thawj zaug hauv cov qog nqaij hlav malignant, uas yog qhov loj tshaj plaws qog nqaij hlav hauv Suav lag luam.
Ntawm lawv, NSCLC suav txog ntau dua 80 feem pua ntawm cov qog nqaij hlav ntsws, kwv yees li 70 feem pua ntawm cov hom nruab nrab. Cov neeg mob uas muaj mob qog noj ntshav nruab nrab thiab qib siab hauv nruab nrab feem ntau nrog cov hlab ntsws loj heev, uas yog qhov nyuaj rau kev phais, kev kho mob hluav taws xob thiab kws khomob, vim yog qhov cuam tshuam ntawm cov hlab ntsws thiab qhov sib thooj atatasis ntawm lub ntsws, uas yog, qhov poob. ntawm ib txwm gas exchange function. Tam sim no, lub cev ablation (xws li laser ablation, freeze-thaw freeze-ablation, thiab microwave) yog siv los tshem cov qog hauv cov hlab ntsws kom qhib lub lumen thiab txo cov hlab ntsws.
Kev ua lag luam loj, tab sis muaj ntau tus neeg sib tw. Tam sim no, muaj ntau lub tuam txhab tshuaj hauv kev kho mob qog noj ntshav, tshwj xeeb tshaj yog nyob rau hauv NSCLC cov tshuaj tsom tau muaj ntau ntau. Raws li tsab ntawv ceeb toom, txij li xyoo 2021, 23 lub hom phiaj tshuaj rau NSCLC tau ua lag luam, 80 feem pua ntawm cov hom phiaj tsom rau EGFR, PD-(L)1 thiab ALK lub hom phiaj.
Guotai Junan ib zaug kwv yees tias kev txhaj tshuaj toluene sulfonamide muaj kev cia siab dav hauv kev kuaj mob qog thiab pab kho qog, uas xav kom ncav cuag 1 billion yuan sai. Nyob rau 22nd, raws li qhov zoo ntawm cov npe ntawm cov tshuaj benzene sulfonamide, cov khoom lag luam ntawm Hongri Pharmaceutical dhia ze li 3 feem pua. Ua ntej ntawd, cov khoom lag luam ntawm Hongri Pharmaceutical tau nce ntau dua 50 feem pua ntawm cov hauv qab. Tej zaum nws yuav yog lub khw tseem muaj kev cia siab rau kev txhaj tshuaj benzene sulfonamide.
Hauv ob peb xyoos dhau los, kev nce qib tseem ceeb tau ua tiav hauv kev kho mob ntsws cancer, tshwj xeeb tshaj yog hauv kev kho mob NSCLC. Txoj kev kho mob tau maj mam hloov los ntawm cov tshuaj chemical thiab chemotherapy rau kev kho mob, immunotherapy thiab txawm tias cell thiab noob kho. Immunotherapy, uas yog sawv cev los ntawm PD-1 txoj kev kho, tau maj mam dhau los ua qhov tseem ceeb ntawm kev tshawb fawb, thiab nws tsis paub meej tias qhov muag ntim ntawm 1 billion yeej yuav ua tiav vim yog txoj cai cuam tshuam xws li kev sib tham txog kev pov hwm kho mob thiab kev sau.
Hongri Pharmaceutical yog ib lub tuam txhab ua lag luam ntawm TCM formula granule nyob rau hauv Suav teb, nrog ntau tshaj 600 hom mis granule khoom, pib npog tag nrho cov ntau yam nrog lub siab tshaj plaws zaus ntawm TCM kev kho mob siv.
Tab sis nyob rau hauv xyoo tas los no nyob rau hauv cov tshuaj innovation tshuaj kuj muaj ntau layout. Raws li daim ntawv tshaj tawm 2022 ib nrab xyoo ntawm Hongri Pharmaceutical, lub tuam txhab tab tom tsim ntau tshaj 30 txoj haujlwm, suav nrog 5 1.1 cov tshuaj tshiab (KB, PTS, Chav Kawm ntawm cov tshuaj tshiab tshuaj tiv thaiv kab mob siab C, ML{{5 }} thiab Amdiphene ntsiav tshuaj (PD-L1)), tag nrho cov tshuaj yog tshuaj. Tam sim no, Hongri Pharmaceutical thaum kawg tau txais kev pom zoo ntawm thawj chav kawm 1 cov tshuaj tshiab, txawm hais tias kev sib tw hnyav, nws tseem yog qhov tseem ceeb ntawm txoj kev tshiab, thiab tau txais kev paub zoo rau kev tshaj tawm cov tshuaj tshiab tom ntej.